Outcomes of Device Closure of Atrial Septal Defects.
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ABSTRACT:
SUBMITTER: Rao PS
PROVIDER: S-EPMC7552712 | biostudies-literature | 2020 Aug
REPOSITORIES: biostudies-literature
Publications
Outcomes of Device Closure of Atrial Septal Defects.
Children (Basel, Switzerland) 20200825 9
Several devices have been designed and tried over the years to percutaneously close atrial septal defects (ASDs). Most of the devices were first experimented in animal models with subsequent clinical testing in human subjects. Some devices were discontinued or withdrawn from further clinical use for varied reasons and other devices received Food and Drug Administration (FDA) approval with consequent continued usage. The outcomes of both discontinued and currently used devices was presented in so ...[more]
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Project description:BackgroundAtrial tachyarrhythmias (ATs) are a major source of morbidity in the atrial septal defect (ASD) patient cohort. The optimal timing and approach of anti-arrhythmic intervention is currently unclear. Here, we sought to determine the overall rate of ATs following percutaneous ASD closure and risk factors that may predict this.MethodsA systematic search of the literature was performed using the search terms '(Secundum Atrial Septal Defects AND Atrial arrhythmias) AND (transcatheter closure or percutaneous closure or device closure)'. All studies in English reporting the rate of ATs following percutaneous closure of secundum ASDs in adult patients were included. The primary outcome was documented AT detection during follow-up ECG monitoring. A meta-regression was then performed to test for an interaction between demographic/procedural characteristics and the primary outcome.Results13 observational studies including 2366 patients were analysed. The overall post-procedure AT event detection rate was 8.6%. Multivariate meta-regression analysis revealed that only male gender was associated with a higher rate of post-procedure AT detection while utilisation of the Amplatzer Septal Occluder device was associated with a lower AT detection rate and comprised 96.2% of all devices used. A high level of heterogeneity was observed (I2-statistic 92.3%, Q value 156.8).ConclusionsOur study illustrates that despite percutaneous ASD closure, a high proportion of adult patients have ATs with male gender correlating with higher AT rates. While the Amplatzer Septal Occluder device correlated with lower AT rates, this was the overwhelmingly the predominant device used hence comparison to other devices remains challenging.
| S-EPMC7063168 | biostudies-literature
Project description:Background Transcatheter closure of atrial septal defects (ASDs) is well-established. However, this procedure can be challenging, requiring multiple attempts and advanced implantation maneuvers. Materials and methods From July 2019 to July 2022, patients to whom the fast atrial sheath traction (FAST) technique was applied for ASD device closure were prospectively followed up. The device was rapidly unsheathed in the middle of the left atrium (LA) to let it clamp the ASD from both sides simultaneously. This novel technique was directly applied in patients with absent aortic rims and/or ASD size-to-body weight ratio higher than 0.9 or after failed attempts of standard implantation. Results Seventeen patients (64.7% males) were involved with a median age of 9.8 years [interquartile range (IQR), 7.6–15.1] and a median weight of 34 kg (IQR, 22–44). The median ASD size on ultrasound was 19 mm (IQR, 16–22). Five (29.4%) patients had absent aortic rims, and three (17.6%) patients had an ASD size-to-body weight ratio higher than 0.9. The median device size was 22 mm (IQR, 17–24). The median difference between device size and ASD two-dimensional static diameter was 3 mm (IQR, 1–3). All interventions were straightforward without any complications using three different occluder devices. One device was removed before release and upsized to the next size. The median fluoroscopy time was 4.1 min (IQR, 3.6–4.6). All patients were discharged the next postoperative day. On a median follow-up of 13 months (IQR, 8–13), no complications were detected. All patients achieved full clinical recovery with complete shunt closure. Conclusion We present a new implantation technique to efficiently close simple and complex ASDs. The FAST technique can be of benefit in overcoming left disc malalignment to the septum in defects with absent aortic rims and in avoiding complex implantation maneuvers and the risks of injuring the pulmonary veins.
| S-EPMC10239810 | biostudies-literature
Project description:AimsThe aim of this study was to evaluate the safety and efficacy of transcatheter closure for perimembranous ventricular septal defect (pmVSD) and its long-term results. The most common congenital heart condition is pmVSD. Transcatheter closure of pmVSD is a recently described technique with limited results for mid- to long-term follow-up.Methods and resultsBetween June 2002 and June 2008, 848 patients with pmVSD were enrolled in our study and treated percutaneously with pmVSD occluders. All patients were followed up until December 2008, an average of 37 months. According to colour Doppler transthoracic echocardiography before the intervention and ventriculography, the average end-diastolic pmVSD size was 5.1 and 5.4 mm, respectively. Placement of the device was successful in 832 patients (98.1%) and the median device size was 8.6 mm. During follow-up, 103 adverse events (12.4%) were reported. Most adverse events were categorized as minor and there were nine major adverse events (8.7%), including two complete atrioventricular block requiring pacemaker implantation. Kaplan-Meier estimates showed >85% freedom from major or minor adverse events during a maximal follow-up of 79 months.ConclusionsIn experienced hands, transcatheter pmVSD closure can be performed safely and successfully with low morbidity and mortality. Long-term prognostic results are favourable, and the transcatheter approach provides a less-invasive alternative that may become the first choice in selected pmVSD patients. This trial is registered with ClinicalTrials.gov, number NCT00890799.
| S-EPMC2938468 | biostudies-literature
Project description:Deficient retro-aortic rim is of concern as a risk factor for aortic erosion after device closure of atrial septal defects (ASD). However, its prevalence and contribution to technical failure and adverse outcomes have not been delineated. A single-center retrospective cohort study of children and adults undergoing cardiac catheterization for device occlusion of ASD from 1 January 1999 to 1 April 2012 was performed. Risk factors for technical failure and early adverse outcome were assessed using multivariate logistic regression. During the study period, 445 consecutive subjects with a median age of 5.9 years (range, 0.8-80 years) underwent catheterization. Of the subjects with reviewable echocardiograms, 60 % had deficient retro-aortic rim. No attempt at device closure was made for 3.6 % of the subjects. Of the remaining 429 subjects, 96 % underwent successful device occlusion. Major early adverse events occurred in 1.2 % (95 % confidence interval 0.4-2.7 %) of the cases, all of them either device embolization or malposition. Deficient retro-aortic rim was not a risk factor for composite outcome of technical failure or early major adverse event. No deaths, late reinterventions, or erosion events occurred during 2,395 total person-years (median, 5.8 years) of follow-up evaluation. Deficient retro-aortic rim was associated with increased risk of device impingement on the aorta, but no association was seen between device impingement or deficient retro-aortic rim and the development of new/progressive aortic insufficiency. Deficient retro-aortic rim is highly prevalent but did not increase the risk of adverse outcomes. Its contribution to the risk of aortic erosion could not be addressed by this study.
| S-EPMC4167195 | biostudies-literature
Project description:An 86-year-old woman experienced hypoxia with right-to-left flow across an iatrogenic atrial septal defect after deployment of a left atrial appendage closure device. Emergent closure of the defect was performed with an atrial septal occluder device with resolution of hypoxia. (Level of Difficulty: Intermediate.).
| S-EPMC9434646 | biostudies-literature
Project description:Background:To evaluate the feasibility of using a single device to close multiple atrial septal defects (ASDs) under the guidance of transthoracic echocardiography (TTE) and with the aid of three-dimensional (3D) printing models. Methods:Sixty-two patients with multiple ASDs were retrospectively analyzed. Thirty of these patients underwent TTE-guided closure (3D printing and TTE group) after a simulation of occlusion in 3D printing models. The remaining 32 patients underwent ASD closure under fluoroscopic guidance (conventional group). Closure status was assessed immediately and at 6 months after device closure. Results:Successful transcatheter closure with a single device was achieved in 26 patients in the 3D printing and TTE group and 27 patients in the conventional group. Gender, age [18.8?±?15.9 (3-51) years in the 3D printing and TTE group; 14.0?±?11.6 (3-50) years in the conventional group], mean maximum distance between defects, prevalence of 3 atrial defects and large defect distance (defined as distance ?7?mm), and occluder size used were similarly distributed between groups. However, the 3D printing and TTE group had lower frequency of occluder replacement (3.8% vs 59.3%, p < 0.0001), prevalence of mild residual shunts (defined as <5?mm) immediately (19.2% vs 44.4%, p < 0.05) and at 6 months (7.7% vs 29.6%, p < 0.05) after the procedure, and cost (32960.8?±?2018.7 CNY vs 41019.9?±?13758.2 CNY, p < 0.01). Conclusion:The combination of the 3D printing technology and ultrasound-guided interventional procedure provides a reliable new therapeutic approach for multiple ASDs, especially for challenging cases with large defect distance.
| S-EPMC7201835 | biostudies-literature
Project description:Purpose of reviewTo review current controversies in the transcatheter device closure of ostium secundum atrial septal defects (ASD).Recent findingsTranscatheter device closure of ASD (TC-ASD) has well established efficacy and safety. For most individual patients with suitable anatomy, TC-ASD is the preferred method for treating ASD. The availability of large multicenter data sets has made it possible to study practice patterns at a range of hospitals across the United States. These studies have revealed differences in practice that were not previously appreciated. Interpretation of the indications for TC-ASD, specifically the definition of right ventricular volume overload varies between hospitals. In response to concern about device erosion, an increasing proportion of patients are being referred for operative ASD closure. Over the last decade, the average age at which ASD closure occurs has decreased. These trends demonstrate previously underappreciated differences in opinion between cardiologists across the country and suggest that further research is necessary to address knowledge gaps limiting consistency of practice.SummaryAs TC-ASD and congenital interventional cardiology mature as a field, studies of real-world practice provide increasingly valuable information about aspects of care in which there are disagreements about best practices and in which further research is necessary.
| S-EPMC6112166 | biostudies-literature
Project description:ObjectiveTo prospectively study the techniques and outcomes of transcatheter closure of complex Atrial septal defects (ASD).Study design and settingsProspective single center study with experience in catheter closure of ASD. All patients with complex ASD suitable for device closure.ObjectiveAnalysis of outcomes of transcatheter closure of complex ASD in JIPMER Hospital over the past 5-year period.MethodsComplex ASD was predefined and patients satisfying inclusion and exclusion criteria are included. All the patients had meticulous Transesophageal echocardiography (TEE) imaging beforehand. Modifications of the conventional techniques were allowed on a case per case basis according to operator preference. Successfully intervened patients were followed up clinically.ResultsOut of the 75 patients enrolled, 69 patients had successful device closure (success rate 92%) despite challenging anatomy. Fifty-six (74%) patients had ASD ≥ 25 mm. Fifteen patients (20%) had defect size ≥ 35 mm and 20 patients (26.6%) had devices implanted with ≥ 35 mm waist size. Fifty percent of patients had complete absence of aortic rim and 25% had deficient posterior rim. Twenty percent of patients had malaligned septum. Mean follow up period was 3.2 years.ConclusionsTrans catheter closure is feasible in anatomically complex substrates of Secundum ASD. Careful case selection, scrupulous imaging protocol, and expertise in modified techniques are mandatory for successful outcomes.
| S-EPMC3946438 | biostudies-literature
Project description:ObjectiveDeficient retro-aortic rim has been identified as a risk factor for device erosion following trans-catheter closure of atrial septal defects (ASDs). Transthoracic echocardiography (TTE) is the primary screening method for subjects for possible device closure of ASD, but its reliability in measuring retro-aortic rim size has not been assessed previously.DesignA single-institution cross-sectional analysis of children and adults referred for trans-catheter device closure of single ostium secundum ASD from January 1, 2005 to April 1, 2012 with reviewable TTE and trans-esophageal echocardiogram images was performed. Inter-rater reliability of measurements was tested in a 24% sample. Accuracy of TTE measurement of retro-aortic rim was assessed using a Bland-Altman plot with trans-esophageal echocardiogram measurement as the gold standard. Test characteristics of TTE detection of deficient retro-aortic rim were calculated. Risk factors for misclassification of deficient retro-aortic rim were assessed using receiver operator characteristic curves. Risk factors for measurement error were assessed through multivariate linear regression.ResultsIn total, 163 subjects of median age 5 years (range: 0.3-46 years) were included. Trans-thoracic echocardiography had 90% sensitivity, 84% specificity, 90% positive predictive value, and 83% negative predictive value to detect deficient retro-aortic rim. Bland-Altman plot demonstrated no fixed bias (P = .23), but errors in measurement increased on average as the aortic rim increased in size (P < .001). Prespecified patient level risk factors did not affect receiver operator characteristic curve area under the curve, nor were any patient-level risk factors independently associated with increased measurement error on TTE.ConclusionsTTE is a sensitive and specific screening test for deficient retro-aortic rim across a range of patient ages and sizes.
| S-EPMC4748720 | biostudies-literature
Project description:Background Current guidelines recommend at least 6 months of antithrombotic therapy and antibiotic prophylaxis after septal-occluding device deployment in transcatheter closure of atrial septal defect. It has been estimated that it takes ≈6 months for complete neo-endothelialization; however, neo-endothelialization has not previously been assessed in vivo in humans. Methods and Results The neointimal coverage of septal occluder devices was evaluated 6 months after implantation in 15 patients by angioscopy from the right atrium. Each occluder surface was divided into 9 areas; the levels of endothelialization in each area were semiquantitatively assessed by 4-point grades. Device neo-endothelialization was sufficient in two thirds of patients, but insufficient in one third. In the comparison between patients with sufficiently endothelialized devices of average grade score ≥2 (good endothelialization group, n=10) and those with poorly endothelialized devices of average grade score <2 (poor endothelialization group, n=5), those in the poor endothelialization group had larger devices deployed (27.0 mm [25.0-31.5 mm] versus 17.0 mm [15.6-22.5 mm], respectively) and progressive right heart dilatation. The endothelialization was poorer around the central areas. Moreover, the prevalence of thrombus formation on the devices was higher in the poorly endothelialized areas than in the sufficiently endothelialized areas (Grade 0, 94.1%; Grade 1, 63.2%; Grade 2, 0%; Grade 3, 1.6%). Conclusions Neo-endothelialization on the closure devices varied 6 months after implantation. Notably, poor endothelialization and thrombus attachment were observed around the central areas and on the larger devices.
| S-EPMC8649546 | biostudies-literature